Panels › Clinical Chemistry › Product code JKA · Class 2
Tubes, Vials, Systems, Serum Separators, Blood Collection
Regulation 862.1675
8510(k)s in 12 months (239 all time)
14recalls in 12 months (171 all time)
156recalls that name a 510(k)
Top companies in JKA
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 12, 2014 | Fresenius Medical Care Holdings, Inc. BD Vacutainer EDTA Tubes (LAVENDER TOP TUBE 2.0ML)
Part Number: BD 367841
Part Number: FMC 87-7841-7
Single use tube used to collect, separate, transport or process blood specimens for laboratory de Terminated |
JKA | K921806 |
| Sep 12, 2014 | Fresenius Medical Care Holdings, Inc. BD Vacutainer Serum Tubes (RED TOP PLAIN TUBE 6.0 ML)Part Number: BD 367815
FMC Part Number: 87-7815-4
Single use tube used to collect, separate, transport or process blood specimens for laboratory Terminated |
JKA | K960250 |
| Mar 12, 2014 | Smiths Medical ASD, Inc. G2001: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device, Needle-Pro Device and 23G x 1 needle
Arterial Blood Sampling Line Draw Syringes are sterile, Terminated |
JKA | K952516 |
| Mar 12, 2014 | Smiths Medical ASD, Inc. G1777: Umbilical (2) 3 mL Line Draw, Luer lock syringes (heparin concentration: 23.5 I.U. per mL) with Filter-Pro devices and (2) Needle-Pro Devices with 22G x 1needles
Arterial Blood Sampling Line Terminated |
JKA | K952516 |
| Mar 12, 2014 | Smiths Medical ASD, Inc. G1762: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device, syringe tip cap, and 5 mL Luer lock syringe
Arterial Blood Sampling Line Draw Syringes are s Terminated |
JKA | K952516 |
| Mar 12, 2014 | Smiths Medical ASD, Inc. G1725: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device and 1 mL Line Draw Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro Terminated |
JKA | K952516 |
| Mar 12, 2014 | Smiths Medical ASD, Inc. G1469J: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device (for sale in Japan only)
Arterial Blood Sampling Line Draw Syringes are sterile, single-use Terminated |
JKA | K952516 |
| Mar 12, 2014 | Smiths Medical ASD, Inc. 4043E: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device (for sale in Europe only)
Arterial Blood Sampling Line Draw Syringes are sterile, single-use Terminated |
JKA | K952516 |
| Mar 12, 2014 | Smiths Medical ASD, Inc. 4042E: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device (for sale in Europe only)
Arterial Blood Sampling Line Draw Syringes are sterile, single-use Terminated |
JKA | K952516 |
| Mar 12, 2014 | Smiths Medical ASD, Inc. 4042LH: 3 mL Line Draw, Luer lock syringe (heparin concentration: 7 I.U. per mL)with Filter-Pro device
Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnost Terminated |
JKA | K952516 |
| Mar 12, 2014 | Smiths Medical ASD, Inc. 4043W-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device, syringe tip cap and 6 mL Luer slip syringe
Arterial Blood Sampling Line Draw Syringes are Terminated |
JKA | K952516 |
| Mar 12, 2014 | Smiths Medical ASD, Inc. 4043G-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device and ice bag
Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in Terminated |
JKA | K952516 |
| Mar 12, 2014 | Smiths Medical ASD, Inc. 4043-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device
Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagno Terminated |
JKA | K952516 |
| Mar 12, 2014 | Smiths Medical ASD, Inc. 4042-2: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device
Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagno Terminated |
JKA | K952516 |
| Mar 12, 2014 | Smiths Medical ASD, Inc. 4040-2: Umbilical 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device, 22g x 1 needle, and Point-Lok needle safety device
Arterial Blood Sampling Line D Terminated |
JKA | K952516 |
| Oct 18, 2013 | Perkin Elmer Health Sciences, Inc. Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900.
The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood Terminated |
JKA | K121864 |
| Aug 7, 2013 | Becton Dickinson & Company BD Vacutainer Multiple Sample and Direct Draw Luer Adapter
BD Franklin Lakes, NJ 07417 USA
A sterile non-invasive device used to connect venous access devices such as needles, blood collection sets, Terminated |
JKA | None listed |
| Mar 6, 2013 | Becton Dickinson & Company BD Vacutainer PST Gel and Lithium Heparin (LH); 83 Units; Plus Blood Collection Tubes; Sterile; IVD; REF 367962; 4.5 mL, 13 X 100 mm; BD, Franklin Lakes, NJ USA; Made in USA.
Used in hospitals, outpa Terminated |
JKA | K945952 |
| Nov 12, 2012 | Becton Dickinson & Company BD Vacutainer Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes; Sterile; IVD; REF 363083; 13 X 75 mm, 2.7 mL Terminated |
JKA | K013971 |
| Feb 24, 2012 | Capitol Vial Inc Oral-Eze (R) Oral Fluid Collection System, manufactured by Capitol Vial, Inc., Auburn, AL 36832
Product Usage:
IVD for drugs of abuse Terminated |
JKA | K984361 |
| Feb 22, 2012 | Greiner Bio-One North America, Inc. LH Lithium Heparin tubes, Greiner bio-one, North America, 4238 Capital Drive, Monroe, NC 28110.
Venous blood collection tubes. Terminated |
JKA | K960857 |
| Jan 11, 2012 | Heritage Labs International LLC Heritage Labs Blood/Urine Collection Kit, Product A1100, packed in bags in bulk, 25 kits/shipping carton. Each kit contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, blood Terminated |
JKA | K883787 |
| Jan 11, 2012 | Heritage Labs International LLC Biometric Combo Test Kit, Product K8500, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, blood specimen collection supplies and Terminated |
JKA | K993787 |
| Jan 11, 2012 | Heritage Labs International LLC AGLH - Lung Health Study, Specimen Collection & Return Kit, Phlebotomy & Urine Kit, Product A2351, 10 kits/shipping carton, each kit contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 507 Terminated |
JKA | K993787 |
| Jan 11, 2012 | Heritage Labs International LLC Bravo Wellness Kit, Product A1778, each kit packed in a bag or envelope. Each kit contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, blood specimen collection supplies, a Terminated |
JKA | K993787 |
| Nov 25, 2011 | Immunetech Inc ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No.
8024, Provider Pack: 5 test,
Product is manufactured distributed by ImmuneTech, Inc., Foster City, CA; but the
non-sterile al Terminated |
JKA | K021698 K061979 |
| Nov 25, 2011 | Immunetech Inc ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No.
8021, Screening Pack: 100 test (with lancet & capillary),
Product is manufactured distributed by ImmuneTech, Inc., Foster City, Terminated |
JKA | K021698 K061979 |
| Nov 25, 2011 | Immunetech Inc ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No.
8015, Screening Pack: 50 test (with lancet),
Product is manufactured distributed by ImmuneTech, Inc., Foster City, CA; but the Terminated |
JKA | K021698 K061979 |
| Nov 25, 2011 | Immunetech Inc ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No.
8014, Provider Pack: 10 test (without lancet),
Product is manufactured distributed by ImmuneTech, Inc., Foster City, CA; but the Terminated |
JKA | K021698 K061979 |
| Nov 25, 2011 | Immunetech Inc ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No.
8013, Provider Pack: 10 test (with lancet),
Product is manufactured distributed by ImmuneTech, Inc., Foster City, CA; but the Terminated |
JKA | K021698 K061979 |
| Nov 25, 2011 | Immunetech Inc ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No.
8001; Individually Packaged Kit,
Product is manufactured distributed by ImmuneTech, Inc., Foster City, CA; but the
non-steri Terminated |
JKA | K021698 K061979 |
| Nov 14, 2011 | Greiner Bio-One North America, Inc. Greiner bio-one, 4ml K2E EDTA K2 Vacuette tube. Used for venous blood collection. Item number 454209. Terminated |
JKA | K971236 |
| Nov 8, 2011 | Becton Dickinson & Company BD Microtainer MAP Microtube for Automated Process with K2EDTA.
For the collection, transport, and automated processing of skin punctures samples from infants, children, geriatric, oncology, and cr Terminated |
JKA | K093972 |
| Mar 7, 2011 | Covidien LP MONOJECT Blood Collection Tubes containing heparin
10x64 Sodium Heparin
Item code 8881320256 Terminated |
JKA | K883320 |
| Mar 7, 2011 | Covidien LP MONOJECT Blood Collection Tubes containing heparin
10x50 Sodium Heparin
Item code 8881320157 Terminated |
JKA | K883320 |
| Mar 7, 2011 | Covidien LP MONOJECT Blood Collection Tubes containing heparin
13x100 sodium heparin trace element
Item Code 8881307014 Terminated |
JKA | K883320 |
| Dec 16, 2010 | Greiner Bio-One North America, Inc. Vacuette 2 ml Lithium Heparin, Collection Tube, Manufactured by: Greiner-Bio One North America, Inc., 4238 Capital Drive, Monroe, NC.
Venous blood collection tubes. Terminated |
JKA | K960857 |
| Sep 7, 2010 | Whatman, Inc. Whatman Body Fluid Collection Paper- 903 California Newborn Screening Card Ref 110534
903 Card are intended for use by healthcare professionals in the collection and in-vitro storage of neonate human Terminated |
JKA | K932661 |
| Mar 5, 2010 | Whatman, Inc. Whatman Body Fluid Collection Paper 903, Ref: 10534790, for IVD use. Whatman Inc., Florham Park, NJ.
The device is used by healthcare professionals in the collection and in-vitro storage of neonate b Terminated |
JKA | K932661 |
| Sep 30, 2009 | Whatman, Inc. Whatman Body Fluid Collection Paper 903
The device is used by healthcare professionals in the collection and in-vitro storage of neonate blood. Terminated |
JKA | K932661 |
| Nov 7, 2008 | Greiner Bio-One North America, Inc. VACUETTE, 2 ml Lithium Heparin Venous Blood Collection Tubes. Reference #454237, 13x75 green cap-white ring, 24 racks of 50 pcs (1200 pcs in total, non ridged, Sterile). Manufactured by: Greiner bi Terminated |
JKA | K960857 |
| Aug 23, 2008 | StatSpin, Inc., dba Iris Sample Processing StatSampler 200 uL, Li Heparin (micro blood collector)
Ref: SS2H
Packed in Catalog Numbers:
SS2H (I vial), SS2H-06 (6 kits/case), CH2C-I0 (I0 vials/kit)
Intended for collection and processing of cap Terminated |
JKA | K896206 |
| Jul 18, 2008 | Celsus Laboratories Inc Celsus Laboratories Heparin Lithium Lyophilized; Lithium Heparin for use in blood collection tube devices and in vitro diagnostic devices. Terminated |
JKA | None listed |
| Jan 23, 2008 | Becton Dickinson & Company BD Vacutainer Push Button Blood collection Sets with Pre-Attached Holder; Catalog Number: 368656; 23 g X12 " PBBCS w/PAH (Preattached), BD Diagnostics, Franklin Lakes, NJ Terminated |
JKA | K011984 |
| Jan 23, 2008 | Becton Dickinson & Company BD Vacutainer Push Button Blood collection Sets with Pre-Attached Holder;Catalog Number : 367352: 21G x 3/4" x 12"; 0.8 x 19mm x 305mm, Wingset PBBCS, BD Diagnostics, Franklin Lakes, NJ Terminated |
JKA | K011984 |
| May 10, 2007 | Becton Dickinson & Company BD Vacutainer Safety-Lok Blood Collection Set with Preattached Holder. Color green. 21 Gauge. Translucent, integrated protective shield that provides one-handed activation immediately after use, 0.7 Terminated |
JKA | K980414 |
| Dec 6, 2006 | Becton Dickinson & Company BD Vacutainer Luer-Lok Access Device
Holder with Pre-Attached Multiple Sample Adapter
Sterile, Do Not Reuse, Keep away from heat, Rx only
Ref # 364902
200 (4X50)
BD Franklin Lakes, NJ 07417 Terminated |
JKA | K991088 |
| Sep 9, 2006 | Becton Dickinson & Company BD Vacutainer Luer Adapter; Catalog #367290 and #367300. Terminated |
JKA | K991088 |
| Aug 29, 2006 | Radiometer America Inc SafePICO Samplers, self-filling arterial blood samplers. The syringe blood samplers are individually packed in plastic pouches and distributed in cartons. Each carton contains ten (10) boxes and eac Terminated |
JKA | K043143 |
| Oct 22, 2005 | Greiner VACUETTE North America Serum Blood Collection Tubes Terminated |
JKA | K960858 |
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